MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PX260

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Information (3190)

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However the complaint could not be confirmed without the completion of the product evaluation.A supplemental report will be forthcoming with the evaluation and device history results.Additional information regarding the patient condition has been requested from the hospital.

Event Description

It was reported that the dpt (disposable pressure transducer) did not calibrate to zero and gave inaccurate information about the arterial pressure during use on a patient.The pressure curve shown on the monitor did not correspond to the patient clinical status and it was impossible to zero the device.The cables were changed without success.The dpt was changed for another one and the issue was solved.However, the patient was hypotensive due to inotropic drugs being decreased based on the inaccurate values.

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specifications upon release.Multiple follow up attempts to the facility regarding product return and condition of the patient were made.No response has been given by the facility at this time.

Manufacturer Narrative

We received one single dpt kit model px260 for examination.No priming solution was visible inside of the kit.The dpt did not zero or sense pressure.Electrical testing showed that both input and output impedance of the dpt were within specifications.However a short condition was noticed between the #4 solder joint (of input circuit) and #3 trace (of the output circuit).An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

• Brand Name: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5038639
• MDR Text Key: 24432004
• Report Number: 2015691-2015-02222
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2017
• Device Model Number: PX260
• Device Lot Number: 60062180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other